Clinical trial · Interventional
Tolerability Study of Xerecept® in Pediatric Patients
A Phase I/II Open Label Individual Dose Titration Trial of the Human Corticotropin- Releasing Factor (hCRF), Corticorelin Acetate Injection (Xerecept®), to Determine the Tolerability of Xerecept® in a Pediatric Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Single subject remained on study - transferred to compassionate use
Summary
Brief summary (as posted)
This study is being conducted to evaluate the safety and tolerability of Xerecept® in children with central nervous system tumors and to identify appropriate doses of Xerecept® to be used in subsequent pediatric clinical trials.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Edema | — | UNRESOLVED | — |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XERECEPT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Xerecept
- description
- All patients will receive hCRF (XERECEPT)
- interventionNames
- Drug: XERECEPT
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- 2 months
- description
- To define the maximum tolerated dose (MTD) of Xerecept® in pediatric patients; the MTD will be defined as the dose at which 1 or fewer of six patients experiences a dose limiting adverse event of any kind.
Secondary outcomes (5)
- measure
- Dexamethasone Dosing
- timeFrame
- 1 Year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have histologically confirmed primary, recurrent or metastatic cerebral tumors and require chronic steroid dosing to manage symptoms of peritumoral brain edema (No histological confirmation is required of optic pathway tumors or brain stem gliomas) 2. Have been taking dexamethasone (or equivalent) at a dose of ≥1 mg/day for a minimum of 14 days and have had a stable dose for at least 7 days. 3. Have one or more steroid-associated side effects at Screening (See Appendix A1 for a list of qualifying events) 4. Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver. 5. Karnofsky/Lansky performance status ≥ 40 6. Life expectancy of at least 6 months 7. Female subjects must not be pregnant or breast-feeding and, if of childbearing potential, must use adequate methods of contraception during the study 10\. Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed Exclusion Criteria: 1. Evidence of previous or current overt renal, hepatic or pulmonary diseases or active uncontrolled infection 2. Subject and/or parent/guardian is unwilling or unable to comply with this protocol 3. Subject has a known history of allergy or intolerance to hCRF or other ingredients in the Xerecept® solution (e.g., methionine, mannitol) 4. Subject has a known history of hepatitis C virus, hepatitis B surface, or human immunodeficiency virus (HIV).
References
Publications (0)
Data not yet available